Viewing Study NCT00299247



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Study NCT ID: NCT00299247
Status: WITHDRAWN
Last Update Posted: 2019-01-30
First Post: 2006-03-03

Brief Title: SP Resistance and Falciparum Malaria Transmission
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: SP Resistance Markers and Falciparum Malaria Transmission
Status: WITHDRAWN
Status Verified Date: 2010-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to study resistance to current malaria treatments and affordable alternatives for uncomplicated malaria Resistance occurs in areas where these treatments are used frequently This study may help prevent future resistance About 150 residents in Buenaventura Colombia will participate They will have uncomplicated malaria and they will be followed for 28 days after treatment Physical exams and blood draws are included in study visits
Detailed Description: Drug-resistant Plasmodium falciparum is a major threat to global public health and new strategies are needed to deter spread of resistance to available and forthcoming antimalarial drugs This study seeks to contribute to understanding the molecular basis of spread of drug resistance in a setting with low level of sulfadoxine-pyrimethamine SP treatment failure The objectives of this study are to compare the prevalence of dihydrofolate reductase DHFR and dihydropteroate synthase DHPS point mutations associated with SP resistance before and after SP treatment of uncomplicated Plasmodium falciparum malaria episodes and to measure parasite infectivity to Anopheles mosquitoes of post-treatment gametocytes with and without DHFR and DHPR mutations Patients with uncomplicated falciparum malaria will receive a standard SP regimen and will be closely followed for 28 days This study will add new knowledge of the understanding of ways in which resistance is spread and is expected to provide a sound basis for the future clinical evaluation of antimalarial drug combinations designed to prevent transmission of drug-resistance malaria

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None